Trial Information

OBJECTIVES: I. Determine whether epoetin alfa treatment improves the quality of life in
anemic patients who are undergoing chemotherapy for advanced malignancy. II. Determine
whether epoetin alfa increases hemoglobin levels and decreases transfusion requirements in
these patients. III. Validate or refute the use of an algorithm using pre- and posttreatment
epoetin alfa, ferritin, and hemoglobin levels to predict 16 weeks response or no response to
therapeutic doses of epoetin alfa as set forth by these patients. IV. Explore whether anemic
patients receiving platinum-containing chemotherapy regimens experience less nephrotoxicity
if they receive concurrent epoetin alfa compared to those who receive placebo.

OUTLINE: This is a randomized, double blind study. Patients are stratified by primary
malignant disease (lung vs breast vs other), life expectancy (4-6 months vs greater than 6
months), planned concurrent radiotherapy (yes vs no), and degree of anemia (mild or at least
9 g/dL vs severe or less than 9 g/dL). Patients receiving chemotherapy are randomized to
receive epoetin alfa subcutaneously once a week for a maximum of 16 weeks (arm I) or placebo
subcutaneously once a week for a maximum of 16 weeks (arm II). Quality of life is assessed
at randomization and monthly throughout study. Patients are followed every 6 months for 1
year.

PROJECTED ACCRUAL: There will be 300 patients (150 patients per arm) accrued into this study
over 11 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Anemic: Hemoglobin in males less than 11.5 g/dL; hemoglobin in
females less than 10.0 g/dL No anemia secondary to B12, folic acid, or iron deficiency No
anemia secondary to gastrointestinal bleed or hemolysis No anemia secondary to a primary
or chemotherapy-induced myelodysplastic syndrome No anemia secondary to acute lymphocytic
leukemia Histologically confirmed advanced malignancy Lung Breast Other Currently
receiving myelosuppressive, cytotoxic chemotherapy for advanced cancer No patients
receiving adjuvant therapy for cancer that has been surgically removed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At
least 4 months Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal:
Not specified Cardiovascular: No uncontrolled hypertension (systolic at least 180,
diastolic at least 100) Other: Normal or elevated ferritin No known hypersensitivity to
epoetin alfa Must be able to reliably take oral medication Must be alert and mentally
competent Not pregnant or nursing

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